EndoTic - Endothelium and Ticagrelor

EndoTic - Endothelium and Ticagrelor: Pharmacological Effects Beyond Antiplatelet Therapy

Randomized clinical trial to assess the influence of treatment with ticagrelor or clopidogrel in the number of CECs (Circulating Endothelial Cells) and EPCs (Endothelial Progenitor Cells) in patients with ACS (Acute Coronary Syndrome), from baseline levels to chronic levels (1 month).

Study Overview

• Status: Completed
• Conditions: Acute Coronary Syndrome (ACS)
• Intervention / Treatment: Drug: Ticagrelor vs Clopidogrel

Detailed Description

ACS Patients in both treatment groups will be assessed:

Baseline, 48h and 1 month cell counts will be done for CECs and EPCs Platelet Function at 48h and 1month Adverse Events, ECG and blood testing result will be also collected

• Study Type: Interventional
• Enrollment (Actual): 109
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Leon, Spain, 24008
    • Hospital de Leon
  • Salamanca, Spain
    • Hospital Universitario de Salamanca
  • La Coruña
    • Santiago de Compostela, La Coruña, Spain
      • Hospital Universitario de Santiago

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Willing to sign Informed Consent Form
• 18 yr or older
• Male and female (post menopause or contraception treatment)
• ACS diagnosed with elevation of myocardial infarction biomarkers (as of 3rd Universal Definition of MI)
• Planned invasive strategy (coronariography performed within 72hrs after admission)

Exclusion Criteria:

• Aspirin, clopidogrel or ticagrelor allergy.
• Hemorrhagic diathesis or very high risk of bleeding.
• Current treatment with oral anticoagulants, thienopyridines or ticagrelor.
• Limited life expectancy.
• Elective surgery planned.
• High chance of not being able to complete the follow-up period.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ticagrelor; 180mg initial dose next day 90mg BID	Drug: Ticagrelor vs Clopidogrel
Active Comparator: Clopidogrel; 600mg po initial dose and 75mg qd starting next day	Drug: Ticagrelor vs Clopidogrel

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of cells	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)	Baseline
Number of cells	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)	48 hours after last chest pain episode
Number of cells	EPC (Endothelial Progenitor Cells) CEC (Circulating Endothelial Cells)	1 month visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Platelet reactivity	As determined by P2Y12 kits, VerifyNow®	At the time of coronary angiography
Platelet reactivity	As determined by P2Y12 kits, VerifyNow®	1 month visit

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety: Bleeding and ischemic adverse events	Adverse Events collection	18 months (Study duration)

Collaborators and Investigators

• Sponsor: Fundación Investigación Sanitaria en León
• Collaborators: AstraZeneca
• Investigators: Principal Investigator: Armando Pérez de Prado, MD, PhD, Fundación Investigación Sanitaria en León; Study Director: M. Belen Vidriales Acosta, MD, PhD, University of Salamanca

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): September 1, 2016
• Study Completion (Actual): September 1, 2016

Study Registration Dates

• First Submitted: September 11, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): November 23, 2016
• Last Update Submitted That Met QC Criteria: November 22, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Ticagrelor; Endothelial Progenitor Cells; Circulating Endothelial Cells; Acute coronary syndrome (ACS)
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Acute Coronary Syndrome; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Platelet Aggregation Inhibitors; Purinergic P2Y Receptor Antagonists; Purinergic P2 Receptor Antagonists; Purinergic Antagonists; Purinergic Agents; Ticagrelor; Clopidogrel
• Other Study ID Numbers: ISSBRIL0205; 2013-005042-11 (EudraCT Number)